CT Scanner TSX-501R/1 V11.1

The CT Scanner TSX-501R/1 V11.1 is a computed tomography system that acquires and displays cross-sectional images of the whole body (abdomen, pelvis, chest, extremities, and head) in adult patients. It can provide volume sets for specialized diagnostic studies performed by trained physicians using indicated software and hardware.

The primary technological difference is the subject device uses a photon counting detector (0.21 mm × 192 rows) versus the predicate's energy integrating detector (0.25 mm × 160 rows). The subject device offers faster rotation times (0.35–1.0 s vs. 0.23–3.0 s), shorter maximum continuous scan time (50 s vs. 100 s), and similar reconstruction matrices, though image reconstruction time is slower (5 images/s vs. 80 images/s). Both support conventional, helical, volume, and dynamic volume scan modes.

The device conforms to IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC81001-5-1, IEC62366-1, NEMA XR-25, NEMA XR-26, and NEMA XR-29. It complies with radiation safety performance standards in 21 CFR §1010 and §1020, and was tested under Quality System Regulations per 21 CFR §820 and ISO 13485.

The subject device is substantially equivalent because it has the same intended use as the predicate (cross-sectional body imaging in adults) and demonstrated equivalent or improved image quality performance in bench testing across multiple metrics including contrast-to-noise ratio, CT number accuracy, and low contrast detectability. Although the photon counting detector is technologically different, comprehensive bench testing of its fundamental properties (MTF, DQE, artifact analysis, count rate, lag) showed equivalent performance, and clinical diagnostic images from chest, abdomen, brain, and MSK scans were confirmed by board-certified radiologists to be of diagnostic quality.